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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K251352
Device Name Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
Applicant
Codonics.Incorporated
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Applicant Contact Gary Enos
Correspondent
Codonics.Incorporated
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Correspondent Contact Gary Enos
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/30/2025
Decision Date 07/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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